临床营养研究中随机对照研究质量评价

Objective To evaluate the quality of the randomized controlled trials (RCTs) published in two key Chineze journals on clinical nutrition.Methods The articles published in CHINESE JOURNAL OF CLIN-ICAL NUTRlTION and PARENTERAL & ENTERAL NUTRITION from 2000 to 2008 were reviewed and the RCTs were identified according to criteria of the handbook of Cochrane Collaboration.The Jadad scale was used to evalu-ate the quality of these RCTs.Results Totally 238 RCT articles were published in these two journals in this peri-od.The Jadad score of all RCT articles was 1.65±0.82.Twenty-eight articles (11.76%) were of high quality and only 5 articles (2.10%) were identified 5 points.There were some problems in the RCTs design,conduction and analyses included unclear randomization methods,poor comparison,lack of inclusion and exclusion criteria.less blinding employment,unclear withdrawals and dropouts,and improper sample size.Conclusion The design and quality control of Chinese clinical nutrition RCTs still have some problems and require further improvement.     

Modelling the costs and effects of leflunomide in rheumatoid arthritis

This study investigated the cost-effectiveness of leflunomide (LEF) compared to methotrexate (MTX) and sulfasalazine (SSZ) in the United Kingdom. A Markov model was constructed using health states defined by Health Assessment Questionnaire score. The model is based on a cohort of patients with recently diagnosed definite RA who were followed for up to 15 years at nine rheumatology clinics in the UK. The treatment effect was calculated based on clinical trials comparing LEF to MTX (one international and one United States trial) and to SSZ (one international trial). Transitions between health states for the first 2 years of treatment were calculated from the clinical trials, while the extrapolation beyond the trial was based on the Early Rheumatoid Arthritis Study cohort, using an ordered probit model. This makes it possible to predict transitions for patients with similar characteristics (age, time since disease onset) as in the trials. Separate analyses were performed for each trial, and all analyses covered a 10-year timeframe. Using the US trial, LEF had slightly lower costs and better effects (￡44,017 and 4.307 QALYs, compared to ￡44,988 and 4.158 QALYs for MTX), while for the international trial this was reversed (￡34,070 and 4.487 QALYs for MTX compared to ￡36,351 and 4.372 QALYs for LEF). Compared to SSZ, the cost of using LEF was slightly lower, with an increase in QALYs (￡35,855 and 3.896 QALYs compared to ￡36,731 and 3.721 QALYs for SSZ). The two trials comparing LEF to MTX gave differing results. One possible reason for this is that MTX patients in the US trial were given folic acid, whereas in the international trial folate supplementation was not mandated. This may have reduced the effectiveness of MTX. In the UK it is standard practice to use folic acid with MTX, and therefore the results from the US trial may be more relevant for the UK. Compared to SSZ, the use of LEF appears to be cost-effective in the UK.     

中国控烟措施有效性评价研究的系统综述

为系统评价中国控烟研究的质量,总结控烟措施的有效性证据,在多个数据库中检索1990-2009年中国发表的控烟措施有效性评价研究文献,采用美国<社区预防服务指南>制定的方法对文献质量进行评价,并进一步对控烟干预措施的有效性证据强度进行评定.共纳入282项中国控烟干预性评价研究,其中仅75项(26.41%)研究质量较好、能够进入证据评价体系.有效性证据强度评定结果显示,吸烟人群中开展戒烟药物干预和行为干预一般人群中开展多组分干预(如宣传教育+行为干预)的有效性证据充分,而临床咨询、中医疗法、单纯宣传教育、规章制度等干预措施的有效性缺乏充分证据支持.中国控烟干预性研究整体质量较低,高质量研究的数量不足是限制控烟有效性证据产出的主要障碍;应重视和加强对控烟规章制度有效性评价的研究.

Abstract：

To systematically summarize the evidence on the effectiveness of measures regarding tobacco control in China. Papers on several databases published between 1990 and 2009were systematically searched. Methods in American Guide to Community Preventive Services were used to evaluate the quality and strength of evidence on the effectiveness of tobacco control programs.Overall, 282 studies were included in this paper, but only 75 (26.41%) studies had acceptable execution quality. Items as pharmaceutical therapy and behavior intervention in the smoking population that would show sufficient evidence on the effectiveness of the programs. In general population, multi-component intervention programs appeared to be effective. However, the effectiveness regarding items as clinical consultation, therapy with traditional Chinese medicine,education programs alone, non-smoking related laws and regulations etc. were of insufficient evidence. The overall execution quality of intervention studies on tobacco control in China was considered to be poor and few of them would show the evidence on the effectiveness of the programs. Only few studies on non-smoking related laws and regulations touched upon the positive effectiveness on this issue. We suggested that the execution and evaluation on non-smoking related laws and regulations be strengthened.     

构建医疗机构对临床研究助理满意度模型的初探

CRA的工作水平直接影响到临床试验的质量,评价CRA工作绩效水平时,临床机构对其工作的满意度是极为重要的指标.本文通过对山东省16家临床医疗研究机构关于CRA服务满意度进行调查,然后对503份调查样本分别进行探索性因素分析和验证性因素分析,从而探索对满意度的主要影响因素,试图构建适合临床单位对CRA满意度进行评价的模型.

Abstract：

The performance of CRA directly affects the quality of clinical trials. In the appraisal of the CRA performance, satisfaction of clinical institutions plays a vital role. This article presents the outcome of a satisfaction survey on 16 clinical research centers in Shandong province, and the analysis of 503 survey samples regarding their exploratory factor and confirmatory factor respectively. The purpose is to identify the main factors for the satisfaction and to build a model to evaluate the satisfaction of hospitals for CRA.     

藻油及鱼油二十二碳六烯酸复方制剂对儿童记忆功能的影响

目的 研究二十二碳六烯酸(DHA)与大豆磷脂、维生素A复方制剂对儿童记忆功能的影响,并比较藻油和鱼油来源的DHA的作用有无差别.方法 选择上海市宝山区某小学年龄在11到12岁之间且知情同意的健康学生160名,采用随机数字表法将受试者分为3组:藻油DHA组(n=53)、鱼油DHA组(n=53)和对照组(n=54).藻油DHA组服用藻油来源的DHA与大豆磷脂、维生素A复方制剂软胶囊,鱼油DHA组服用鱼油来源的DHA与大豆磷脂、维生素A复方制剂软胶囊,两组的DHA含量相等,均为200 mg/粒,其余成分均相同;对照组服用相同外观的软胶囊安慰剂.3组均连续服用30 d,每天1粒.试验开始及结束时采用中国科学院心理研究所编制的临床记忆量表评价受试者的记忆能力.结果 试验前,3组的各分测验量表分和记忆商差异均无统计学意义(P均>0.05).试验后,藻油DHA组和鱼油DHA组与对照组相比除联想学习差异无统计学意义外(P均>0.05),其他各项量表分及记忆商均明显高于对照组(P均<0.05);藻油DHA组和鱼油DHA组间各分测验量表分和记忆商差异均无统计学意义(P均>0.05).结论 DHA复方制剂对改善儿童记忆力有一定的效果;同等剂量不同来源的DHA对于记忆力的影响无差异.

Abstract：

Objective To study the effects of compound preparations which contain docosahexenoic acid (DHA),soybean lecithin,and vitamin A on memory ability of children and to compare the difference between two compound preparations that contain DHA from marine algae and from fish oil.Methods Totally 160 11-12-year-old healthy children who were studying in a primary school in Baoshan District of Shanghai were enrolled in this study.All the subjects signed the informed consent form.Subjects were randomly divided into three groups with random numbers:marine algae DHA group(n=53),fish oil DHA group(n=53),and control group(n=54).Subjects in the marine algae DHA group were given compound preparation which contained DHA form marine algae,soybean lecithin,and vitamin A;subjects in fish oil DHA group were given compound preparation which contained DHA form fish oil,soybean lecithin,and vitamin A.The dose of DHA(200 mg DHA per capsule)and other components in the two groups was equal.Subjects in the control group were given a placebo with same appearance.The trial lasted 30 days.Each subject took a capsule per day.Immediately before and after the trial,subjects were tested by using the clinical memory scale compiled by the Institute of Clinical Psychology of the Chinese Academy of Sciences.Results Before the trial.there was no difference amongthree groups in terms of all items of clinical memory scale or memory quotient(all P>0.05).After the trial,except for associative learning(both P>0.05),the other items of the clinical memory scale and memory quotient in both marine algae DHA group and fish oil DHA group were significantly higher than those of control group(all P<0.05).No significant difference was noted between the marine algae DHA group and fish oil DHA group for all items of the clinical memory scale or memory quotient(all P>0.05).Conclusions DHA compounds can impreve the memory ability of children.DHAs with different sources have similar effect on memory ability.     

现行医疗质量评价指标体系的缺陷问题刍议

目的 明确现行医疗质量评价指标体系的缺陷问题.方法　以现行医疗质量评价指标体系主要包括中国医院协会(CHA)<医院管理与质量评价标准>(2007年)和卫生部<医院管理评价指南>(2005年)为主要研究对象.以北京市卫生局<北京地区医院管理考核评价标准实施细则>(2007年)、JCI<国际医院评审标准>(第2版)(2003年)和<台湾地区新制医院评鉴标准>(2005年、2006年)作为对照.应用文献分析法研究分析.结果　主要缺陷包括指标可操作性不强,病人诊疗过程角度的评价指标不足.结论 围绕病人就诊过程梳理指标,立足国情,增加病人诊疗过程指标比例,量化并突出指标的可操作性,及时总结逐步优化.

Abstract：

Objective To identify shortcomings in the current evaluation index system of medical quality. Methods The documentary analysis focused on the existing index system comprises the Hospital Management and Quality Evaluation Standards (2007) by China Hospital Association, Hospital Management Evaluation Guidelines (2005) by the Ministry of Health, and Implementation Rules of Hospital Management Evaluation Standards for Beijing (2007). JCI Accreditation Standards for Hospitals (edition 2) (2003), and New Hospital Accreditation Standards for Taiwan (2005, 2006) were referred to in the study. Results The shortcomings found include the weak operability of indexes, and the deficiency of evaluation indexes from the point of hospital visiting process by patients. Conclusion In view of the hospital visiting process of patients, add more indexes for patients' hospital visiting process,and quantize and highlight the operability of indexes, with summary and optimization of experiences in time by steps.     

临床医学科技成果评价指标体系研究

目的 建立一套科学、客观、合理、定性与定量相结合、可操作性强的临床医学科技成果评价指标体系,为科学评价临床医学科技成果提供参考依据.方法 采用Delphi专家咨询法对30位专家进行问卷咨询,确定指标体系及其权重.结果 问卷回收率100%.通过两轮咨询专家意见达到高度统一,专家意见的协调系数为0.963.最终的评价体系包含3个一级指标、8个二级指标和18个三级指标,确定了各级指标的权重.结论 专家积极性和意见一致性高,确立的临床医学科技成果评价指标体系可用于临床医学科技成果的综合评价,对于临床医学科技成果为临床服务,解决临床问题具有导向作用.

Abstract：

Objective To set up a scientific, objective, reasonable, qualitative and quantitative,operational evaluation index system of clinical science and technology achievements, which provides the reference to evaluating clinieal science and technology achievements scientifieally. Methods The Delphi method was used to investigate 30 experts for weight of the index via questionnaire. Results The response rate was 100%. The Kendall's concordance coefficient was up to 0. 963. The final index system includes three first-class indicators, eight second-class indicators and 18 third-class indicators. The weight coefficeient of each class was identified. Conclusion The experts showed enthusiasm for this investigation. The agreement of respondents was high after two rounds of investigation. The index system can be used in comprehensive evaluation for science and technology achievements in clinical medicine. The index system takes a guiding effect for science and technology achievements to solve clinical services and problems.     

Disease progression in amyotrophic lateral sclerosis

This study reports the results of a long-term economic evaluation of riluzole in the treatment of amyotrophic lateral sclerosis (ALS) versus best supportive care in the United Kingdom. The analysis included in this contribution aims to provide an update of the determination of the phase of the disease that is prolonged by riluzole and also to assess the quality of the life extension offered by riluzole by taking into account the patients' utility score. Specifically, the analysis provides a more specific estimate of the cost-utility of riluzole dependent disease stage, thereby providing a useful insight of the cost-effectiveness of therapy. A Markov model was used to assess the cost-effectiveness of riluzole versus best supportive care. Transition possibilities and the distribution of patients by health states were taken from a cohort of 954 patients drawn from a large randomised, double blind, placebo-controlled, multicentre trial between 1992 and 1994. Costs associated with riluzole included the acquisition cost and bi-monthly monitoring for raised ALT levels. Patient assessed utilities were collected by use of the SG technique from two centres (King's, London and Preston) in the UK. Four distinct health states were used corresponding to mild, moderate, severe and terminal states. Applying the Markov model and extending the transitional probabilities using linear interpolation, the base case cost per life year gained was estimated at ￡15,192 while applying Standard Gamble utility scores, the base case cost per quality-adjusted life-year (QALY) was assessed at ￡22,086. Carrying out a probabilistic sensitivity analysis, the cost per QALY was estimated at ￡22,236 with standard deviation of ￡612. The results of the long-term analysis also show that riluzole on average increases survival in ALS patients by 6 months with approximately 5 months of the additional life gained in the early disease states, of which 4 months is spent in disease state 2, where quality of life is relatively high. However, the model is sensitive in the way in which the long-term transitional probabilities are estimated. Using averages of the first nine cycles, the cost per QALY would increase to ￡33,420 with standard deviation of ￡972. Thus, this analysis highlights some of the difficulties associated with extending the short clinical effectiveness data; one way forward would be to obtain long-term observations data for both groups.     

临床实验室质量指标体系探讨

构建有效的临床实验室质量指标体系,可促进实验室质量的持续改进,以保障患者安全.从质量指标的选择、建立、执行和处理的质量循环过程着手,通过实例展示质量指标的建立与应用,提出有计划地采集有用信息来建立质量指标体系的方法,并对实验室管理与控制质量指标的应用进行了详细的说明.认为只有当内部审核计划和实验室间质量评价有机地结合在一起时,才能真正促进临床实验室质量的持续改进.

Abstract：

To provide an effective approach to select, develop, interpret and apply well-designed quality indicators. Then to promote the continual improvement of laboratory quality and to assure patient safety. We focused on the quality cycle of selecting, development, implementation and processing for quality indicators. And some examples for essential activities in the development and use of quality indicators were shown. Through the presentation of process and examples, we put forward an organized approach that provides the laboratory with a plan to structure its development of quality indicators to gather useful information. Quality indicators are important. However, they should be integrated with internal review plan, External Quality Assessment (EQA) and the process of activities in plan. Only then can we really promote the continual improvement of quality.     

北京三级医院医疗质量推荐指标体系的构建

通过分析北京市多家医院的医疗质量评价指标,针对综合医院和专科医院的不同情况,结合文件、文献研究与现场考察、专家咨询,以病人诊疗过程为切入点,围绕"维护病人利益、保障病人安全、提高医疗质量",探索如何构建并优化一套医疗质量评价推荐性指标体系,重点介绍了推荐性指标体系的框架、指标遴选的原则等,并对推荐性指标体系构建的相关问题做了讨论.

Abstract：

To explore how to create and optimize a promotion index system of medical quality evaluation, this article focuses on the hospital visiting process from patients, using analyzing collected those index system from couples of Grade Ⅲ hospitals in Beijing, and combining the results of literal study, field study and specialist consult, according to the different situation of general hospitals and specially hospitals, with the spirit of "maintaining the patients benefits, safeguarding the patients safety,and enhancing the medical quality", introduces the framework of the promotion index system, the rules to select the indicator, and so on, and discusses several problerns related to creating the index system.     

Eliminating bias in randomized controlled trials: importance of allocation concealment and masking

Randomization in randomized controlled trials involves more than generation of a random sequence by which to assign subjects. For randomization to be successfully implemented, the randomization sequence must be adequately protected (concealed) so that investigators, involved health care providers, and subjects are not aware of the upcoming assignment. The absence of adequate allocation concealment can lead to selection bias, one of the very problems that randomization was supposed to eliminate. Authors of reports of randomized trials should provide enough details on how allocation concealment was achieved so the reader can determine the likelihood of success. Fortunately, a plan of allocation concealment can always be incorporated into the design of a randomized trial. Certain methods minimize the risk of concealment failing more than others. Keeping knowledge of subjects' assignment after allocation from subjects, investigators/health care providers, or those assessing outcomes is referred to as masking (also known as blinding). The goal of masking is to prevent ascertainment bias. In contrast to allocation concealment, masking cannot always be incorporated into a randomized controlled trial. Both allocation concealment and masking add to the elimination of bias in randomized controlled trials.     

Discrepancy between published report and actual conduct of randomized clinical trials

Randomized clinical trial (RCT) publications with inappropriate random-sequence generation, lack of allocation concealment, or imperfect blinding yield inflated estimates of effect compared to those in which adequate methods are described. RCTs that do not state methods used yield similar effect estimates, suggesting that inadequate methods were used. We compared RCT publications with investigator reports of actual practice for 40 rheumatology RCTs published in 1997/1998. In RCTs in which these methods were not described in the trial reports and would thus have been characterized as "inadequate," investigators reported using methods of random-sequence generation and allocation concealment that would be considered adequate in 77.4 and 78.1% of RCTs, respectively. This suggests that, in contrast to previous reports, inadequate random-sequence generation and allocation concealment, per se, may not be a major problem in RCTs. Characterizing RCTs as "good" or "poor" quality based on the published report is likely to be inappropriate.     

A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus

BACKGROUND AND OBJECTIVE: To develop a checklist of items measuring the quality of reports of randomized clinical trials (RCTs) assessing nonpharmacological treatments (NPTs). STUDY DESIGN AND SETTING: The Delphi consensus method was used to select and reduce the number of items in the checklist. A total of 154 individuals were invited to participate: epidemiologists and statisticians involved in the field of methodology of RCTs (n = 55), members of the Cochrane Collaboration (n = 41), and clinicians involved in planning NPT clinical trials (n = 58). Participants ranked on a 10-point Likert scale whether an item should be included in the checklist. RESULTS: Fifty-five experts (36%) participated in the survey. They were experienced in systematic reviews (68% were involved in the Cochrane Collaboration) and in planning RCTs (76%). Three rounds of the Delphi method were conducted to achieve consensus. The final checklist contains 10 items and 5 subitems, with items related to the standardization of the intervention, care provider influence, and additional measures to minimize the potential bias from lack of blinding of participants, care providers, and outcome assessors. CONCLUSIONS: This tool can be used to critically appraise the medical literature, design NPT studies, and assess the quality of trial reports included in systematic reviews.     

短期ω-3脂肪酸乳剂干预对手术后肠外营养患者临床结局影响的Meta分析

目的 探讨ω-3脂肪酸乳剂对手术后患者临床结局的影响。方法 计算机检索1996年1月至2010年6月PubMed、EMBASE、Cochrane图书馆、Web of Science以及中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方等中文数据库中研究择期手术后补充ω-3脂肪酸对患者临床结局影响的文献,同时进行手工检索和参考文献回溯。采用Jadad量表结合Schulz隐蔽分组评价方法对随机对照研究的质量进行评价。两组人员独立对研究方法详读综合后进行数据提取。采用RevMan 5.1软件进行Meta分析,研究ω-3脂肪酸乳剂对手术后患者感染并发症发生率、病死率、术后住院时间和术后ICU入住时间的影响。结果 共检索到320篇相关文献,大致符合计划要求的有22篇文献,排除数据重复、抄袭和无法获得方法学资料的文摘,最终纳入17个随机对照研究,合计1213例患者。Meta分析结果显示：ω-3脂肪酸乳剂干预能降低患者手术后感染并发症发生率[RR=0.44,95％CI (0.30,0.64),P＜0.0001],减少住院时间[MD=-1.65,95％CI（-2.72,-0.58）,P=0.003],对术后ICU入住时间无影响[MD=-0.31,95％CI（-1.20,0.58）,P=0.500]。结论 适当剂量和一定干预时间的ω-3脂肪酸乳剂能降低手术后患者感染并发症发生率和减少住院时间。今后需要更多样本量较大、质量较高的随机对照研究,观察ω-3脂肪酸乳剂干预对手术后患者临床结局和成本一效果的影响。     

Testing the Risk of Bias tool showed low reliability between individual reviewers and across consensus assessments of reviewer pairs

ObjectivesTo assess the reliability of the Cochrane Risk of Bias (ROB) tool between individual raters and across consensus agreements of pairs of reviewers and examine the impact of study-level factors on reliability.Study Design and SettingTwo reviewers assessed risk of bias for 154 randomized controlled trials (RCTs). For 30 RCTs, two reviewers from each of four centers assessed risk of bias and reached consensus. We assessed interrater agreement using kappas and the impact of study-level factors through subgroup analyses.ResultsReliability between two reviewers was fair for most domains (κ = 0.24–0.37), except sequence generation (κ = 0.79, substantial). Reliability results across reviewer pairs: sequence generation, moderate (κ = 0.60); allocation concealment and “other sources of bias,” fair (κ = 0.37–0.27); and other domains, slight (κ = 0.05–0.09). Reliability was influenced by the nature of the outcome, nature of the intervention, study design, trial hypothesis, and funding source. Variability resulted from different interpretation of the tool rather than different information identified in the study reports.ConclusionLow agreement has implications for interpreting systematic reviews. These findings suggest the need for detailed guidance in assessing the risk of bias.     

GRADE guidelines: 3. Rating the quality of evidence

This article introduces the approach of GRADE to rating quality of evidence. GRADE specifies four categories—high, moderate, low, and very low—that are applied to a body of evidence, not to individual studies. In the context of a systematic review, quality reflects our confidence that the estimates of the effect are correct. In the context of recommendations, quality reflects our confidence that the effect estimates are adequate to support a particular recommendation. Randomized trials begin as high-quality evidence, observational studies as low quality. “Quality” as used in GRADE means more than risk of bias and so may also be compromised by imprecision, inconsistency, indirectness of study results, and publication bias. In addition, several factors can increase our confidence in an estimate of effect. GRADE provides a systematic approach for considering and reporting each of these factors. GRADE separates the process of assessing quality of evidence from the process of making recommendations. Judgments about the strength of a recommendation depend on more than just the quality of evidence.     

偏倚风险评估系列:(三)交叉设计随机对照试验

针对交叉设计随机对照试验Cochrane偏倚评估工具2.0版本（RoB2.0）的主要内容进行详细介绍,主要阐述了与平行设计RoB2.0的不同之处,并举例说明交叉设计RoB2.0的使用方法和注意事项。交叉设计RoB2.0针对交叉设计的自身特点,设置了相应的信号问题,为交叉设计试验纳入系统综述进行证据整合提供偏倚风险信息。     

Cochrane reviews used more rigorous methods than non-Cochrane reviews: survey of systematic reviews in physiotherapy

ObjectiveTo describe the quality and methods of systematic reviews of physiotherapy interventions, compare Cochrane and non-Cochrane reviews, and establish the interrater reliability of the Overview Quality Assessment Questionnaire (OQAQ) quality assessment tool.Study Design and SettingA survey of 200 published systematic reviews was done. Two independent raters assessed the search strategy, assessment of trial quality, outcomes, pooling, conclusions, and overall quality (OQAQ). The study was carried out in the University research center.ResultsIn these reviews, the five most common databases searched were MEDLINE, EMBASE, Cochrane Library, CINAHL, and Cochrane Review Group Registers. The Cochrane allocation concealment system and Jadad Scale were most frequently used to assess trial quality. Cochrane reviews searched more databases and were more likely to assess trial quality, report dichotomous outcomes for individual trials, and conduct a meta-analysis than non-Cochrane reviews. Non-Cochrane reviews were more likely to conclude that there was a beneficial effect of treatment. Cochrane reviews were of higher quality than non-Cochrane reviews. There has been an increase in the quality of systematic reviews over time. The OQAQ has fair to good interrater reliability.ConclusionThe quality of systematic reviews in physiotherapy is improving, and the use of Cochrane Collaboration procedures appears to improve the methods and quality.